Class 1 Device Recall LeadCare Ultra Blood Lead Test Kit

• Date Initiated by Firm: May 07, 2021
• Date Posted: July 01, 2021
• Recall Status: Terminated on October 24, 2023
• Recall Number: Z-1954-2021
• Recall Event ID: 87992
• 510(K)Number: K123563
• Product Classification: Lead, atomic absorption - Product Code DOF
• Product: LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098
• Code Information: Lot Numbers/Expiration Date: 2011MU - 25MAR22. 1st expansion 6/21/2021: 2104MU - 25AUG22; 2108MU - 31MAR22.
• Recalling Firm/ Manufacturer: Magellan Diagnostics, Inc.; 101 Billerica Ave Bldg 4; North Billerica MA 01862-1271
• For Additional Information Contact: Mike West; 978-856-2339
• Manufacturer Reason for Recall: Magellan has received reports that control tests of either the Low-Control and/or the High-Control generated a low result. The issue may cause the underestimation of blood lead levels in patient samples.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On May 17, 2021, Magellan issued an Urgent Medical Device Removal notice to customers and distributors via letter notifying them Magellan has identified an ongoing issue with testing of the controls included in specified lots of LeadCareII Blood Lead Test Kits, LeadCare Plus Blood Lead Test Kits, and LeadCare Ultra Blood Lead Test Kits. REQUIRED ACTIONS: LeadCare blood lead test kits, Catalog Numbers: 70-6762, 82-0004, and 70-8098 - Per laboratory policies and procedures, laboratories should evaluate patient test results that were generated with the impacted lots. - Magellan is recommending retesting of suspect results below 5 mg/dL. - All blood Lead test results should be shared with the patient s physician for interpretation and to determine when retesting and follow-up care are necessary. - Review current inventory and segregate any remaining stock. - Discontinue use of any remaining stock. - Contact Magellan Technical Support 1-800-275-0102 to obtain a FedEx label to return any remaining inventory to Magellan Diagnostics, Inc. and receive replacement product (replacement product is currently available). - Promptly complete and return the Customer Notification Form (this will indicate receipt of this field correction notice). Complete this form even if you have no remaining inventory. On June 23, 2021, Magellan expanded their recall to include an additional product lot by placing telephone calls to the primary distributors. Magellan will issue an Expanded Urgent Medical Device Recall notice to all impacted customers via certified mail starting June 30,2021. Customers are advised to review inventory, segregate and discontinue use of all impacted products. Therefore, patient testing should not be performed (using any of the impacted lots) until resolution of the issue. Immediate Actions: - Review current inventory and segregate any remaining stock. - Discontinue use of any remaining stock. - Promptly complete and return the Customer Notification Form below t
• Quantity in Commerce: 441 kits (192 tests/kit = 84,672 tests)
• Distribution: Worldwide distribution. US nationwide including Puerto Rico; Canada, Vietnam, India, Italy, Peru, New Zealand, Australia, Hong Kong, and Philippines.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DOF